RESTYLANE-L
Report
- Report Number
- 9710154-2019-00036
- Event Type
- Injury
- Date Received
- June 10, 2019
- Date of Event
- February 22, 2019
- Report Date
- October 1, 2019
- Manufacturer
- GALDERMA Q-MED
- Product Code
- LMH
- PMA / PMN Number
- P040024/S039
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
MANUFACTURER NARRATIVE: THE REPORTED LOT NUMBER WAS VALID. PHARMACOVIILANCE COMMENT: THE SERIOUS EVENTS OF SWELLING AND CUTANEOUS CONTOUR DEFORMITY WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. THE SERIOUS EVENTS OF SUICIDAL IDEATION, DEPRESSED MOOD AND SELF-INJURIOUS IDEATION WERE CONSIDERED UNEXPECTED AND UNRELATED TO THE TREATMENT. SERIOUS CRITERIA FOR SUICIDAL IDEATION ALSO INCLUDE LIFE-THREATENING STATUS DUE TO THE SEVERE ASSOCIATED BEHAVIOR REPORTED SUCH AS INTENT OF SELF INJURY. SERIOUS CRITERIA FOR BOTH THE RELATED AND UNRELATED EVENTS INCLUDE THE NEED FOR MULTIPLE MEDICAL INTERVENTIONS TO PREVENT PERMANENT DAMAGE. THE NON-SERIOUS, EXPECTED EVENTS OF NODULE, PAIN, SWELLING, DERMATITIS AND INDURATION AT THE IMPLANT SITE, AND GRANULOMA SKIN, AND THE NON-SERIOUS, UNEXPECTED EVENT OF SKIN TIGHTNESS WERE CONSIDERED POSSIBLY RELATED TO THE TREATMENT. THE NON-SERIOUS, EXPECTED EVENT OF PYREXIA AND UNEXPECTED EVENT OF PAIN (GENERAL BODY) WERE CONSIDERED UNRELATED TO THE TREATMENT. THE NON-SERIOUS EVENTS OF GASTROINTESTINAL DISORDER AND ABDOMINAL DISTENSION WERE CONSIDERED UNEXPECTED AND UNRELATED TO THE TREATMENT BUT POSSIBLY RELATED TO THE CORRECTIVE TREATMENT WITH DOXYCYCLINE. THE PATIENT'S MEDICAL, SOCIAL AND PSYCHOLOGICAL HISTORY WAS NOT REPORTED. THE CASE MEETS THE SERIOUSNESS CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. CAPA COMMENT: THE INFORMATION IN THIS SINGLE CASE DOES NOT SUGGEST INVOLVEMENT OF A NONCONFORMING PRODUCT OR QUALITY PROBLEM AND WILL NOT INITIATE A CORRECTIVE OR PREVENTIVE ACTION. PREVIOUSLY SUBMITTED UNDER EXEMPTION NUMBER: GALDERMA LABORATORIES L.P. IS SUBMITTING THIS REPORT ON BEHALF OF Q-MED AB. PREVIOUSLY SUBMITTED UNDER EXEMPTION NUMBER: GALDERMA LABORATORIES L.P. IS SUBMITTING THIS REPORT ON BEHALF OF Q-MED AB. EXEMPTION NUMBER E2015005
MANUFACTURER NARRATIVE: THE REPORTED LOT NUMBER WAS VALID. PHARMACOVIILANCE COMMENT: THE SERIOUS EVENTS OF SWELLING AND CUTANEOUS CONTOUR DEFORMITY WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. THE SERIOUS EVENTS OF SUICIDAL IDEATION, DEPRESSED MOOD AND SELF-INJURIOUS IDEATION WERE CONSIDERED UNEXPECTED AND UNRELATED TO THE TREATMENT. SERIOUS CRITERIA FOR SUICIDAL IDEATION ALSO INCLUDE LIFE-THREATENING STATUS DUE TO THE SEVERE ASSOCIATED BEHAVIOR REPORTED SUCH AS INTENT OF SELF INJURY. SERIOUS CRITERIA FOR BOTH THE RELATED AND UNRELATED EVENTS INCLUDE THE NEED FOR MULTIPLE MEDICAL INTERVENTIONS TO PREVENT PERMANENT DAMAGE. THE NON-SERIOUS EVENTS OF NODULE, PAIN, AND SWELLING AND INDURATION AT THE IMPLANT SITE WERE CONSIDERED EXPECTED AND POSSIBLY RELATED TO THE TREATMENT. THE NON-SERIOUS EVENTS OF GASTROINTESTINAL DISORDER AND ABDOMINAL DISTENSION WERE CONSIDERED UNEXPECTED AND UNRELATED TO THE TREATMENT BUT POSSIBLY RELATED TO THE CORRECTIVE TREATMENT WITH DOXYCYCLINE. THE PATIENT'S MEDICAL, SOCIAL AND PSYCHOLOGICAL HISTORY WAS NOT REPORTED. THE CASE MEETS THE SERIOUSNESS CRITERIA FOR EXPEDITED REPORTING TO THE REGULATORY AUTHORITIES. CAPA COMMENT: THE INFORMATION IN THIS SINGLE CASE DOES NOT SUGGEST INVOLVEMENT OF A NONCONFORMING PRODUCT OR QUALITY PROBLEM AND WILL NOT INITIATE A CORRECTIVE OR PREVENTIVE ACTION. EXEMPTION:GALDERMA LABORATORIES L.P. IS SUBMITTING THIS REPORT ON BEHALF OF Q-MED AB. EXEMPTION NUMBER E2015005
CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON (B)(6)2019 BY A PHYSICIAN WHICH REFERS TO A 56-YEAR-OLD PERSIAN FEMALE PATIENT WITH SKIN TYPE FITZPATRICK III-IV. ADDITIONAL FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6)2019 AND (B)(6)2019. THE PATIENT HAD NO HISTORY OF ALLERGIES OR AUTOIMMUNE OR OTHER DISEASES. THE PATIENT HAD PREVIOUSLY RECEIVED TREATMENT WITH BOTOX TO FOREHEAD AND GLABELLAR REGION IN (B)(6)2018, VOLUMA ON (B)(6)2018, (B)(6)2017, (B)(6)2015,(B)(6)2015, AND (B)(6)2013 AT ZYGOMA, CHIN AND NASOLABIAL AREA AND VELOUR ON (B)(6)2018 AND (B)(6)2017 AT ZYGOMA, NASOLABIAL AREA, AND RESTYLANE-L SINCE 2012 UNTIL 2018 WITHOUT ANY PROBLEMS TO JAW, ZYGOMA, NASOLABIAL AREA ((B)(6)2018, (B)(6)2018,(B)(6)2016, (B)(6)2015, (B)(6)2014, (B)(6)2014 AND (B)(6)2013). THE PATIENT HAD ALSO RECEIVED VOLBELLA ON (B)(6)2017 TO LIPS AND ULTRA PLUS ON (B)(6)2015 AND (B)(6)2014. CONCOMITANT TREATMENT INCLUDED BOTOX [BOTOX] TO FOREHEAD, GLABELLAR REGION AND CROWS FEET ON (B)(6)2018. ON (B)(6)2019, THE PATIENT WAS AGAIN INJECTED WITH BOTOX TO FOREHEAD AND GLABELLAR AREAS. ON (B)(6)2018, THE PATIENT RECEIVED TREATMENT WITH 1 ML RESTYLANE-L (LOT NUMBER 15292, EXP. DATE 21-DEC-2019), 0.5ML ON EACH SIDE OF THE CHEEKS, ZYGOMA AND JAWLINE AREAS (UNKNOWN NEEDLE TYPE AND INJECTION TECHNIQUE). ON (B)(6)2019, AROUND 3.5 MONTHS AFTER THE TREATMENT, THE PATIENT EXPERIENCED THREE TENDER (IMPLANT SITE PAIN) NODULES (IMPLANT SITE NODULE) OF 1 CM EACH ON THE LEFT SIDE OF THE JAWLINE AND CHIN. THE HCP INJECTED WYDASE [HYALURONIDASE] AND THE PATIENT WAS PLACED ON DOXYCYCLINE [DOXYCYCLINE] 60MG PER DAY. THE PATIENT HAD RESPONDED DOXYCYCLINE, PREDNISONE AND WYDASE [HYALURONIDASE] INITIALLY. LATER NEW NODULES APPEARED. ON (B)(6)2019, THE NODULES ON JAWLINE WERE SOMEWHAT IMPROVED BUT THE CHIN NODULE (LEFT) HAD NOT IMPROVED. IN ADDITION, A SMALL NODULE ON THE RIGHT SIDE OF CHIN HAD DEVELOPED. THE HCP REPORTED THAT THE PATIENT HAD ONLY BEEN ABLE TO FINISH A WEEK OF THE DOXYCYCLINE TREATMENT PREVIOUSLY PRESCRIBED DUE TO GI SIDE EFFECTS (GASTROINTESTINAL DISORDER). ADDITIONALLY, THE PATIENT HAD RECEIVED BOTOX INJECTIONS IN THE FOREHEAD AND GLABELLAR AREAS ON (B)(6)2019. THE HCP CONTINUED TO SEE THE PATIENT WEEKLY THROUGH MARCH AND APRIL, AND TREATED HER WITH TWO COURSES OF STEROIDS, ADVIL [IBUPROFEN] THRICE A DAY AND ANOTHER TRIAMCINOLONE [TRIAMCINOLONE] INJECTION ON (B)(6)2019, A COURSE OF ANTIBIOTICS IN APRIL (WITH A DIFFERENT TETRACYCLINE-TYPE ANTIBIOTIC, SARECYCLINE [SARECYCLINE]), AND WYDASE INJECTIONS. THE NODULES CONTINUED TO APPEAR ON HER JAWLINE AND BEGAN TO APPEAR IN HER NLF AND CHEEKS. AT TIMES THERE WOULD BE SOME IMPROVEMENT, BUT ON THE NEXT VISIT THE NODULES WOULD COME BACK AND WERE MORE WIDESPREAD. IN (B)(6)2019, THE PATIENT'S FACIAL SWELLING(SWELLING) HAD ALSO INCREASED DRAMATICALLY. AS OF THE LAST TIME THE HCP SAW THE PATIENT, WHICH WAS ON (B)(6)2019, HER EYES WERE ALMOST SWOLLEN SHUT AND HER JAWLINE WAS SWOLLEN(IMPLANT SITE SWELLING) AND HARD LIKE WOOD(IMPLANT SITE INDURATION). THE HCP STATED THE PATIENT LOOKED DISFIGURED. 170 DAYS LATER, ON (B)(6)2019, THE PATIENT EXPERIENCED FEVER (PYREXIA), LOTS OF BODY PAIN(PAIN) AND PATIENT WAS OKAY. THE PATIENT ALSO FELT HEAVY FACE AND HARD TIME WHILE WEARING GLASSES BECAUSE WHICH BURNS HER SKIN. THE PATIENT CAN NOT MOVE HER LIPS BECAUSE FACE IS SO TIGHT(SKIN TIGHTNESS). THE PATIENT HAD UNDERGONE SEVERAL BLOOD TEST, X-RAY OF FACE AND CHEST ON AN UNKNOWN DATE IN (B)(6)2019, BIOPSY ON (B)(6)2019 AND MRI ON (B)(6)2019 (RESULT PENDING). THE PATIENT HAD ALSO EXPERIENCED GRANULOMATOUS(GRANULOMA SKIN) DERMATITIS(IMPLANT SITE DERMATITIS) BUT NO INFECTION. THE PATIENT WAS SCHEDULED TO MEET HCP AGAIN ON (B)(6)2019. THE HCP STATED SHE PLANNED TO DO A BIOPSY OF ONE OF THE NODULES. SHE HAS ALSO REFERRED THE PATIENT TO AN INTERNAL MEDICINE DOCTOR TO RULE OUT CANCER. SHE STATED THE BLOOD WORK DONE WAS NORMAL, BUT THEY ARE NOW WAITING FOR SCANS BECAUSE THE PATIENT HAD SOME SWELLING IN ABDOMEN(ABDOMINAL DISTENSION). IT WAS ALSO REPORTED BY HCP THAT THE ADVERSE EVENTS HAD NOT RESOLVED. THE PATIENT FACE IS DISFIGURED (CUTANEOUS CONTOUR DEFORMITY). THE PATIENT WAS SUICIDAL (SUICIDAL IDEATION) AND EXTREMELY DEPRESSED (DEPRESSED MOOD). THE PATIENT HAD EXPRESSED INTENT OF SELF HARM (SELF-INJURIOUS IDEATION). THE PATIENT HAD RECEIVED SEVERAL ROUNDS OF PREDNISONE [PREDNISONE], 60, 40 AND 20 MG AND SERTRALINE [SERTRALINE]. ON (B)(6)2019, THE PATIENT WAS TREATED WITH MEDROL DOSE PACK [METHYLPREDNISOLONE] AND 5-FU [FLUOROURACIL]. OUTCOME AT THE TIME OF THE REPORT: FACIAL SWELLING WAS RECOVERED/RESOLVED. SWOLLEN WAS RECOVERED/RESOLVED. FACE IS DISFIGURED WAS UNKNOWN. PATIENT IS SUICIDAL WAS UNKNOWN. EXPRESSED INTENT OF SELF HARM WAS UNKNOWN. EXTREMELY DEPRESSED WAS UNKNOWN. NODULES WAS NOT RECOVERED/NOT RESOLVED. HARD LIKE WOOD WAS RECOVERED/RESOLVED. TENDER/BURNS MY SKIN WAS NOT RECOVERED/NOT RESOLVED. SOME SWELLING IN ABDOMEN WAS NOT RECOVERED/NOT RESOLVED. GI SIDE EFFECTS WAS UNKNOWN. FEVER WAS RECOVERING/RESOLVING. LOTS OF BODY PAIN WAS RECOVERING/RESOLVING. FACE IS SO TIGHT WAS UNKNOWN. GRANULOMATOUS WAS UNKNOWN. DERMATITIS WAS UNKNOWN. TRACKING LIST: V.0 INITIAL V.1 FU RECEIVED ON (B)(6)2019: EVENTS SUICIDAL IDEATION, DEPRESSED MOOD, INTENTIONAL SELF-INJURY AND CUTANEOUS CONTOUR DEFORMITY WERE ADDED. V.2 FU RECEIVED ON (B)(6)2019: NEW EVENTS ADDED. PAST DEVICE IMPLANT DATES, LOCATION, LAB DETAILS AND CORRECTIVE TREATMENT DETAILS UPDATED.
CASE REFERENCE NUMBER (B)(4) IS A SPONTANEOUS REPORT SENT ON 30-APR-2019 BY A PHYSICIAN WHICH REFERS TO A (B)(6) FEMALE PATIENT. ADDITIONAL FOLLOW UP INFORMATION WAS RECEIVED ON (B)(6) 2019. THE PATIENT HAD NO HISTORY OF ALLERGIES OR AUTOIMMUNE OR OTHER DISEASES. THE PATIENT HAD PREVIOUSLY RECEIVED TREATMENT WITH BOTOX TO FOREHEAD AND GLABELLAR REGION IN (B)(6) 2018, VOLUMA AND VELOUR ON (B)(6) 2018, AND RESTYLANE-L SINCE 2012 UNTIL 2018 WITHOUT ANY PROBLEMS (2018, (B)(6) 2015 AND (B)(6) 2018). CONCOMITANT TREATMENT INCLUDED BOTOX [BOTOX] TO FOREHEAD, GLABELLAR REGION AND CROWS FEET ON (B)(6) 2018. ON (B)(6) 2019, THE PATIENT WAS AGAIN INJECTED WITH BOTOX TO FOREHEAD AND GLABELLAR AREAS. ON (B)(6) 2018, THE PATIENT RECEIVED TREATMENT WITH 1 ML RESTYLANE-L (LOT NUMBER 15292, EXP. DATE 21-DEC-2019), 0.5ML ON EACH SIDE OF THE CHEEKS AND JAWLINE AREAS (UNKNOWN NEEDLE TYPE AND INJECTION TECHNIQUE). ON (B)(6) 2019, AROUND 3.5 MONTHS AFTER THE TREATMENT, THE PATIENT EXPERIENCED THREE TENDER (IMPLANT SITE PAIN) NODULES (IMPLANT SITE NODULE) OF 1 CM EACH ON THE LEFT SIDE OF THE JAWLINE AND CHIN. THE HCP INJECTED WYDASE [HYALURONIDASE] AND THE PATIENT WAS PLACED ON DOXYCYCLINE [DOXYCYCLINE] 60MG PER DAY. ON (B)(6) 2019, THE NODULES ON JAWLINE WERE SOMEWHAT IMPROVED BUT THE CHIN NODULE (LEFT) HAD NOT IMPROVED. IN ADDITION, A SMALL NODULE ON THE RIGHT SIDE OF CHIN HAD DEVELOPED. THE HCP REPORTED THAT THE PATIENT HAD ONLY BEEN ABLE TO FINISH A WEEK OF THE DOXYCYCLINE TREATMENT PREVIOUSLY PRESCRIBED DUE TO GI SIDE EFFECTS (GASTROINTESTINAL DISORDER). ADDITIONALLY, THE PATIENT HAD RECEIVED BOTOX INJECTIONS IN THE FOREHEAD AND GLABELLAR AREAS ON (B)(6) 2019. THE HCP CONTINUED TO SEE THE PATIENT WEEKLY THROUGH MARCH AND APRIL, AND TREATED HER WITH TWO COURSES OF STEROIDS, ADVIL [IBUPROFEN] THRICE A DAY AND ANOTHER TRIAMCINOLONE [TRIAMCINOLONE] INJECTION ON (B)(6) 2019, A COURSE OF ANTIBIOTICS IN APRIL (WITH A DIFFERENT TETRACYCLINE-TYPE ANTIBIOTIC, SARECYCLINE [SARECYCLINE]), AND WYDASE INJECTIONS. THE NODULES CONTINUED TO APPEAR ON HER JAWLINE AND BEGAN TO APPEAR IN HER NLF AND CHEEKS. AT TIMES THERE WOULD BE SOME IMPROVEMENT, BUT ON THE NEXT VISIT THE NODULES WOULD COME BACK AND WERE MORE WIDESPREAD. IN (B)(6) 2019, THE PATIENT'S FACIAL SWELLING(SWELLING) HAD ALSO INCREASED DRAMATICALLY. AS OF THE LAST TIME THE HCP SAW THE PATIENT, WHICH WAS ON (B)(6) 2019, HER EYES WERE ALMOST SWOLLEN SHUT AND HER JAWLINE WAS SWOLLEN(IMPLANT SITE SWELLING) AND HARD LIKE WOOD(IMPLANT SITE INDURATION). THE HCP STATED THE PATIENT LOOKED DISFIGURED. THE PATIENT WAS SCHEDULED TO MEET HCP AGAIN ON (B)(6) 2019. THE HCP STATED SHE PLANNED TO DO A BIOPSY OF ONE OF THE NODULES. SHE HAS ALSO REFERRED THE PATIENT TO AN INTERNAL MEDICINE DOCTOR TO RULE OUT CANCER. SHE STATED THE BLOOD WORK DONE WAS NORMAL, BUT THEY ARE NOW WAITING FOR SCANS BECAUSE THE PATIENT HAD SOME SWELLING IN ABDOMEN(ABDOMINAL DISTENSION). IT WAS ALSO REPORTED BY HCP THAT THE ADVERSE EVENTS HAD NOT RESOLVED. THE PATIENT FACE IS DISFIGURED (CUTANEOUS CONTOUR DEFORMITY). THE PATIENT WAS SUICIDAL (SUICIDAL IDEATION) AND EXTREMELY DEPRESSED (DEPRESSED MOOD). THE PATIENT HAD EXPRESSED INTENT OF SELF HARM (SELF-INJURIOUS IDEATION). OUTCOME AT THE TIME OF THE REPORT: PATIENT IS SUICIDAL WAS UNKNOWN. NODULES WAS NOT RECOVERED/NOT RESOLVED. FACIAL SWELLING WAS NOT RECOVERED/NOT RESOLVED. HARD LIKE WOOD WAS NOT RECOVERED/NOT RESOLVED. SWOLLEN WAS NOT RECOVERED/NOT RESOLVED. TENDER WAS NOT RECOVERED/NOT RESOLVED. SOME SWELLING IN ABDOMEN WAS NOT RECOVERED/NOT RESOLVED. GI SIDE EFFECTS WAS UNKNOWN. EXTREMELY DEPRESSED WAS UNKNOWN. EXPRESSED INTENT OF SELF HARM WAS UNKNOWN. FACE IS DISFIGURED WAS UNKNOWN. TRACKING LIST: V.0 INITIAL. V.1 FU RECEIVED ON (B)(6) 2019: EVENTS SUICIDAL IDEATION, DEPRESSED MOOD, INTENTIONAL SELF-INJURY AND CUTANEOUS CONTOUR DEFORMITY WERE ADDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 476324 | RESTYLANE-L | IMPLANT, DERMAL, FOR AESTHETIC USE | LMH | GALDERMA Q-MED | 15292 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Life Threatening| R | BOTOX| BOTOX| BOTOX |